Lantus

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Read this “Patient Information” that comes with LANTUS
(LAN-tus) before you start using it and each time you get a refill because
there may be new information. This leaflet does not take the place of talking
with your healthcare provider about your condition or treatment. If you have
questions about LANTUS or about diabetes, talk with your healthcare provider.

What is the most important information I should know
about LANTUS?

Do not change the insulin you are using without talking
to your healthcare provider. Any change of insulin should be made
cautiously and only under medical supervision. Changes in insulin strength,
manufacturer, type (for example: Regular, NPH, analogs), species (beef, pork,
beef-pork, human) or method of manufacture (recombinant DNA versus
animal-source insulin) may need a change in the dose. This dose change may be
needed right away or later on during the first several weeks or months on the
new insulin. Doses of oral anti-diabetic medicines may also need to change, if
your insulin is changed.

You must test your blood sugar levels while using an
insulin, such as LANTUS. Your healthcare provider will tell you how often
you should test your blood sugar level, and what to do if it is high or low.

Do NOT dilute or mix LANTUS with any other insulin or
solution. It will not work and you may lose blood sugar control, which
could be serious.

Your body needs insulin to turn sugar (glucose) into
energy. If your body does not make enough insulin, you need to take more
insulin so you will not have too much sugar in your blood.

Insulin injections are important in keeping your diabetes
under control. But the way you live, your diet, careful checking of your blood
sugar levels, exercise, and planned physical activity, all work with your
insulin to help you control your diabetes.

What is LANTUS?

LANTUS (insulin glargine [recombinant DNA origin]) is a
long-acting insulin. . Because Lantus is made by recombinant DNA technology
(rDNA) and is chemically different from the insulin made by the human body, it is
called an insulin analog. LANTUS is used to treat patients with diabetes for
the control of high blood sugar. It is used once a day to lower blood glucose.

LANTUS is a clear, colorless, sterile solution for
injection under the skin (subcutaneously).

The active ingredient in LANTUS is insulin glargine. The
concentration of insulin glargine is 100 units per milliliter (mL), or U-100.
LANTUS also contains zinc, metacresol, glycerol, and water for injection as
inactive ingredients. Hydrochloric acid and/or sodium hydroxide may be added to
adjust the pH.

You need a prescription to get LANTUS. Always be sure you
receive the right insulin from the pharmacy.

Who should NOT take LANTUS?

Do not take LANTUS if you are allergic to insulin
glargine or any of the inactive ingredients in LANTUS. Check with your
healthcare provider if you are not sure.

Before starting LANTUS, tell your healthcare provider
about all your medical conditions including if you:

have liver or kidney problems. Your dose may need
to be adjusted.

are pregnant or plan to become pregnant. It is not
known if LANTUS may harm your unborn baby. It is very important to maintain
control of your blood sugar levels during pregnancy. Your healthcare provider
will decide which insulin is best for you during your pregnancy.

are breast-feeding or plan to breast-feed. It is
not known whether LANTUS passes into your milk. Many medicines, including
insulin, pass into human milk, and could affect your baby. Talk to your
healthcare provider about the best way to feed your baby.

are taking any other medicines including prescription
and non-prescription medicines, vitamins and herbal supplements.

How should I use LANTUS?

See the “Instructions for SoloStar® Use”
section for additional information.

Follow the instructions given by your healthcare provider
about the type or types of insulin you are using. Do not make any changes with
your insulin unless you have talked to your healthcare provider. Your insulin
needs may change because of illness, stress, other medicines, or changes in
diet or activity level. Talk to your healthcare provider about how to adjust
your insulin dose.

You may take LANTUS at any time during the day but you
must take it at the same time every day.

Only use LANTUS that is clear and colorless. If your
LANTUS is cloudy or slightly colored, return it to your pharmacy for a
replacement.

Inject LANTUS under your skin (subcutaneously) in your
upper arm, abdomen (stomach area), or thigh (upper leg). Never inject it into a
vein or muscle.

Change (rotate) injection sites within the same body
area.

NEEDLES AND SOLOSTAR® MUST NOT BE SHARED.

Disposable needles should be used only once. Used needle
should be placed in sharps containers (such as red biohazard containers), hard
plastic containers (such as detergent bottles), or metal containers (such as an
empty coffee can). Such containers should be sealed and disposed of properly.

Mixing with LANTUS

Do NOT dilute or mix LANTUS with any other insulin or
solution. It will not work as intended and you may lose blood sugar
control, which could be serious.

Instructions for SoloStar® Use

It is important to read, understand, and follow the
step-by-step instructions in the “SoloStar® Instruction Leaflet”
before using SoloStar® disposable insulin Pen. Failure to follow the
instructions may result in getting too much or too little insulin. If you
have lost your leaflet or have a question, go to www.lantus.com or call
1-800-633-1610.

The following general notes should be taken into
consideration before injecting Lantus:

Always attach a new needle before use. BD Ultra-Fine™
needles† are compatible with SoloStar. These are sold separately and
are manufactured by BD.

Always perform the safety test before use.

Check the insulin solution in the pen to make sure it is
clear, colorless, and free of particles. If it is not, throw it away.

Do NOT mix or dilute LANTUS with any other insulin or
solution. LANTUS will not work if it is mixed or diluted and you may lose blood
sugar control, which could be serious.

Decide on an injection area - either upper arm, thigh, or
abdomen. Do not use the same injection site as your last injection.

After injecting LANTUS, leave the needle in the skin for
an additional 10 seconds. Then pull the needle straight out. Gently press on
the spot where you injected yourself for a few seconds. Do not rub the area.

Do not drop the SoloStar® disposable insulin
Pen.

If your blood glucose reading is high or low, tell your
healthcare provider so the dose can be adjusted.

What can affect how much insulin I need?

Illness. Illness may change how much insulin you
need. It is a good idea to think ahead and make a ”sick day” plan
with your healthcare provider in advance so you will be ready when this
happens. Be sure to test your blood sugar more often and call your healthcare
provider if you are sick.

Medicines. Many medicines can affect your insulin
needs. Other medicines, including prescription and non-prescription
medicines, vitamins, and herbal supplements, can change the way insulin works.
You may need a different dose of insulin when you are taking certain other
medicines. Know all the medicines you take, including prescription and
non-prescription medicines, vitamins and herbal supplements. You may want to
keep a list of the medicines you take. You can show this list to your
healthcare provider and pharmacists anytime you get a new medicine or refill.
Your healthcare provider will tell you if your insulin dose needs to be
changed.

Meals. The amount of food you eat can affect your
insulin needs. If you eat less food, skip meals, or eat more food than usual,
you may need a different dose of insulin. Talk to your healthcare provider if
you change your diet so that you know how to adjust your LANTUS and other
insulin doses.

Alcohol. Alcohol, including beer and wine, may affect
the way LANTUS works and affect your blood sugar levels. Talk to your
healthcare provider about drinking alcohol.

Exercise or Activity level. Exercise or activity
level may change the way your body uses insulin. Check with your healthcare
provider before you start an exercise program because your dose may need to be
changed.

Travel. If you travel across time zones, talk with
your healthcare provider about how to time your injections. When you travel,
wear your medical alert identification. Take extra insulin and supplies with
you.

Pregnancy or nursing. The effects of LANTUS on an
unborn child or on a nursing baby are unknown. Therefore, tell your healthcare
provider if you planning to have a baby, are pregnant, or nursing a baby. Good
control of diabetes is especially important during pregnancy and nursing.

Hypoglycemia is often called an “insulin
reaction” or “low blood sugar”. It may happen when you do not
have enough sugar in your blood. Common causes of hypoglycemia are illness,
emotional or physical stress, too much insulin, too little food or missed
meals, and too much exercise or activity.

Early warning signs of hypoglycemia may be different,
less noticeable or not noticeable at all in some people. That is why it is
important to check your blood sugar as you have been advised by your healthcare
provider.

Hypoglycemia can happen with:

Taking too much insulin. This can happen when too
much insulin is injected.

Not enough carbohydrate (sugar or starch) intake. This can happen if a meal or snack is missed or delayed.

Vomiting or diarrhea that decreases the amount of
sugar absorbed by your body.

Intake of alcohol.

Medicines that affect insulin. Be sure to discuss
all your medicines with your healthcare provider. Do not start any new
medicines until you know how they may affect your insulin dose.

Medical conditions that can affect your blood sugar
levels or insulin. These conditions include diseases of the adrenal glands,
the pituitary, the thyroid gland, the liver, and the kidney.

Too much glucose use by the body. This can happen
if you exercise too much or have a fever.

Injecting insulin the wrong way or in the wrong
injection area.

Hypoglycemia can be mild to severe. Its onset may be
rapid. Some patients have few or no warning symptoms, including:

If you have hypoglycemia often or it is hard for you to know
if you have the symptoms of hypoglycemia, talk to your healthcare provider.

Mild to moderate hypoglycemia is treated by eating or
drinking carbohydrates such as fruit juice, raisins, sugar candies, milk or
glucose tablets. Talk to your healthcare provider about the amount of
carbohydrates you should eat to treat mild to moderate hypoglycemia.

Severe hypoglycemia may require the help of another
person or emergency medical people. A person with hypoglycemia who is unable to
take foods or liquids with sugar by mouth, or is unconscious needs medical help
fast and will need treatment with a glucagon injection or glucose given
intravenously (IV). Without medical help right away, serious reactions or even
death could happen.

Hyperglycemia (high blood sugar):

Hyperglycemia happens when you have too much sugar in
your blood. Usually, it means there is not enough insulin to break down the
food you eat into energy your body can use. Hyperglycemia can be caused by a
fever, an infection, stress, eating more than you should, taking less insulin
than prescribed, or it can mean your diabetes is getting worse.

Hyperglycemia can happen with:

Insufficient (too little) insulin. This can happen from:

injecting too little or no insulin

incorrect storage (freezing, excessive heat)

use after the expiration date.

Too much carbohydrate intake. This can happen if
you eat larger meals, eat more often, or increase the amount of carbohydrate in
your meals.

Medicines that affect insulin. Be sure to discuss
all your medicines with your healthcare provider. Do not start any new
medicines until you know how they may affect your insulin dose.

Testing your blood or urine often will let you know if
you have hyperglycemia. If your tests are often high, tell your healthcare
provider so your dose of insulin can be changed.

Hyperglycemia can be mild or severe. It can progress
to diabetic ketoacidosis (DKA) or very high glucose levels (hyperosmolar coma)
and result in unconsciousness and death.

Although diabetic ketoacidosis occurs most often in
patients with type 1 diabetes, it can also happen in patients with type 2
diabetes who become very sick. Because some patients get few symptoms of
hyperglycemia, it is important to check your blood sugar/urine sugar and
ketones regularly.

Symptoms of hyperglycemia include:

confusion or drowsiness

increased thirst

decreased appetite, nausea, or vomiting

rapid heart rate

increased urination and dehydration (too little fluid in
your body).

Symptoms of DKA also include:

fruity smelling breath

fast, deep breathing

stomach area (abdominal) pain.

Severe or continuing hyperglycemia or DKA needs
evaluation and treatment right away by your healthcare provider.

Do not use LANTUS to treat diabetic ketoacidosis.

Other possible side effects of LANTUS include:

Serious allergic reactions:

Some times severe, life-threatening allergic reactions
can happen with insulin. If you think you are having a severe allergic
reaction, get medical help right away. Signs of insulin allergy include:

Injecting insulin can cause the following reactions on
the skin at the injection site:

little depression in the skin (lipoatrophy)

skin thickening (lipohypertrophy)

red, swelling, itchy skin (injection site reaction).

You can reduce the chance of getting an injection site
reaction if you change (rotate) the injection site each time. An injection site
reaction should clear up in a few days or a few weeks. If injection site
reactions do not go away or keep happening call your healthcare provider.

Tell your healthcare provider if you have any side
effects that bother you.

These are not all the side effects of LANTUS. Ask your
healthcare provider or pharmacist for more information.

How should I store LANTUS?

Unopened SoloStar®:
Store new unopened SoloStar® disposable insulin pen in a
refrigerator (not the freezer) between 36°F to 46°F (2°C to 8°C). Do not freeze
LANTUS. Keep LANTUS out of direct heat and light. If a disposable insulin pen
has been frozen or overheated, throw it away.

Open (In-Use) SoloStar®:
Once SoloStar® is opened (in-use), SoloStar® should NOT
be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct
heat and light. The opened (in-use) SoloStar® kept at room
temperature must be discarded after 28 days.

These storage conditions are summarized in the following
table:

Not in-use (unopened) Refrigerated

Not in-use (unopened) Room Temperature

In-use (opened) Room Temperature (Do not refrigerate)

3 mL SoloStar® disposable insulindevice

Until expiration date

28 days

28 days

Do not use SoloStar® with LANTUS after the
expiration date stamped on the label.

Do not use LANTUS if it is cloudy, colored, or if you see
particles.

General Information about
LANTUS

Use LANTUS only to treat your diabetes. Do not give or
share LANTUS with another person, even if they have diabetes also. It may harm
them.

This leaflet summarizes the most important information
about LANTUS. If you would like more information, talk with your healthcare
provider. You can ask your healthcare provider or pharmacist for information
about LANTUS that is written for healthcare professionals. For more information
about LANTUS call 1-800-633-1610 or go to website www.lantus.com.

ADDITIONAL INFORMATION

DIABETES FORECAST is a national magazine designed
especially for patients with diabetes and their families and is available by
subscription from the American Diabetes Association (ADA), P.O. Box 363, Mt.
Morris, IL 61054-0363, 1-800-DIABETES (1-800-342-2383). You may also visit the
ADA website at www.diabetes.org. Another publication, COUNTDOWN, is
available from the Juvenile Diabetes Research Foundation International (JDRF),
120 Wall Street, 19th Floor, New York, New York 10005, 1800-JDF-CURE
(1-800-533-2873). You may also visit the JDRF website at www.jdf.org.

To get more information about diabetes, check with your
healthcare professional or diabetes educator or visit www.DiabetesWatch.com.

Additional information about LANTUS can be obtained by
calling 1-800-633-1610 or by visiting www.lantus.com.

Read this “Patient Information” that comes with LANTUS
(LAN-tus) before you start using it and each time you get a refill because
there may be new information. This leaflet does not take the place of talking
with your healthcare provider about your condition or treatment. If you have
questions about LANTUS or about diabetes, talk with your healthcare provider.

What is the most important information I should know
about LANTUS?

Do not change the insulin you are using without
talking to your healthcare provider. Any change of insulin should be made
cautiously and only under medical supervision. Changes in insulin strength,
manufacturer, type (for example: Regular, NPH, analogs), species (beef, pork,
beef-pork, human) or method of manufacture (recombinant DNA versus animal
source insulin) may need a change in the dose. This dose change may be needed
right away or later on during the first several weeks or months on the new
insulin. Doses of oral anti-diabetic medicines may also need to change, if your
insulin is changed.

You must test your blood sugar levels while using an
insulin, such as LANTUS. Your healthcare provider will tell you how often
you should test your blood sugar level, and what to do if it is high or low.

Do NOT dilute or mix LANTUS with any other insulin or
solution. It will not work and you may lose blood sugar control, which
could be serious.

Your body needs insulin to turn sugar (glucose) into
energy. If your body does not make enough insulin, you need to take more
insulin so you will not have too much sugar in your blood.

Insulin injections are important in keeping your diabetes
under control. But the way you live, your diet, careful checking of your blood
sugar levels, exercise, and planned physical activity, all work with your
insulin to help you control your diabetes.

What is LANTUS?

LANTUS (insulin glargine [recombinant DNA origin]) is a
long-acting insulin. Because LANTUS is made by recombinant DNA technology
(rDNA) and is chemically different from the insulin made by the human body, it
is called an insulin analog. LANTUS is used to treat patients with diabetes for
the control of high blood sugar. It is used once a day to lower blood sugar.

LANTUS is a clear, colorless, sterile solution for
injection under the skin (subcutaneously).

The active ingredient in LANTUS is insulin glargine. The
concentration of insulin glargine is 100 units per milliliter (mL), or U-100.
LANTUS also contains zinc, metacresol, glycerol, polysorbate 20 and water for
injection as inactive ingredients. Hydrochloric acid and/or sodium hydroxide
may be added to adjust the pH.

You need a prescription to get LANTUS. Always be sure you
receive the right insulin from the pharmacy. The carton and vial should look like
the ones in this picture.

Who should NOT take LANTUS?

Do not take LANTUS if you
are allergic to insulin glargine or any of
the inactive ingredients in LANTUS. Check with your healthcare provider if you
are not sure.

Before starting LANTUS, tell
your healthcare provider about all your medical conditions including if you:

have liver or kidney
problems. Your dose may need to be
adjusted.

are pregnant or plan to
become pregnant. It is not known if LANTUS
may harm your unborn baby. It is very important to maintain control of your
blood sugar levels during pregnancy. Your healthcare provider will decide which
insulin is best for you during your pregnancy.

are breast-feeding or plan to breast-feed. It is
not known whether LANTUS passes into your milk. Many medicines, including
insulin, pass into human milk, and could affect your baby. Talk to your
healthcare provider about the best way to feed your baby.

about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

How should I use LANTUS?

See the “Instructions for Use” including
the “How do I draw the insulin into the syringe?” section for
additional information.

Follow the instructions given by your healthcare provider
about the type or types of insulin you are using. Do not make any changes with
your insulin unless you have talked to your healthcare provider. Your insulin
needs may change because of illness, stress, other medicines, or changes in
diet or activity level. Talk to your healthcare provider about how to adjust
your insulin dose.

You may take LANTUS at any time during the day but you
must take it at the same time every day.

Only use LANTUS that is clear and colorless. If your
LANTUS is cloudy or slightly colored, return it to your pharmacy for a
replacement.

Inject LANTUS under your skin (subcutaneously) in your
upper arm, abdomen (stomach area), or thigh (upper leg). Never inject it into a
vein or muscle.

Change (rotate) injection sites within the same body
area.

What kind of syringe should I use?

Always use a syringe that is marked for U-100 insulin. If
you use other than U-100 insulin syringe, you may get the wrong dose of insulin
causing serious problems for you, such as a blood sugar level that is too low
or too high. Always use a new needle and syringe each time you give LANTUS
injection.

NEEDLES AND SYRINGES MUST NOT BE SHARED.

Disposable syringes and needles should be used only once.
Used syringe and needle should be placed in sharps containers (such as red
biohazard containers), hard plastic containers (such as detergent bottles), or
metal containers (such as an empty coffee can). Such containers should be
sealed and disposed of properly.

Mixing with LANTUS

Do NOT dilute or mix LANTUS with any other insulin or
solution. It will not work as intended and you may lose blood sugar
control, which could be serious.

Instructions for Use

How do I draw the insulin into the syringe?

The syringe must be new and does not contain any other
medicine.

Do not mix LANTUS with any other type of insulin.

Follow these steps:

1. Wash your hands with soap and water or with alcohol.

2. Check the insulin to make sure it is clear and
colorless. Do not use the insulin after the expiration date stamped on the
label, if it is colored or cloudy, or if you see particles in the solution.

3. If you are using a new vial, remove the protective
cap. Do not remove the stopper.

4. Wipe the top of the vial
with an alcohol swab. You do not have to shake the vial of LANTUS before use.

5. Use a new needle and syringe
every time you give an injection. Use disposable syringes and needles only
once. Throw them away properly. Never share needles and syringes.

6. Draw air into the syringe
equal to your insulin dose. Put the needle through the rubber top of the vial
and push the plunger to inject the air into the vial.

7. Leave the syringe in the
vial and turn both upside down. Hold the syringe and vial firmly in one hand.

8. Make sure the tip of the
needle is in the insulin. With your free hand, pull the plunger to withdraw the
correct dose into the syringe.

9. Before you take the needle out of the vial, check the
syringe for air bubbles. If bubbles are in the syringe, hold the syringe
straight up and tap the side of the syringe until the bubbles float to the top.
Push the bubbles out with the plunger and draw insulin back in until you have
the correct dose.

10. Remove the needle from the vial. Do not let the
needle touch anything. You are now ready to inject.

How do I inject LANTUS?

Inject LANTUS under your skin. Take LANTUS as prescribed
by your healthcare provider.

Follow these steps:

1. Decide on an injection area - either upper arm, thigh
or abdomen. Injection sites within an injection area must be different from one
injection to the next.

2. Use alcohol or soap and water to clean the injection
site. The injection site should be dry before you inject.

3. Pinch the skin. Stick the needle in the way your
healthcare provider showed you. Release the skin.

4. Slowly push in the plunger of the syringe all the way,
making sure you have injected all the insulin. Leave the needle in the skin for
about 10 seconds.

5. Pull the needle straight out and gently press on the
spot where you injected yourself for several seconds. Do not rub the area.

6. Follow your healthcare provider's instructions for
throwing away the used needle and syringe. Do not recap the used needle. Used
needle and syringe should be placed in sharps containers (such as red biohazard
containers), hard plastic containers (such as detergent bottles), or metal
containers (such as an empty coffee can). Such containers should be sealed and
disposed of properly.

What can affect how much insulin I need?

Illness. Illness may change how much insulin you
need. It is a good idea to think ahead and make a “sick day” plan
with your healthcare provider in advance so you will be ready when this
happens. Be sure to test your blood sugar more often and call your healthcare
provider if you are sick.

Medicines. Many medicines can affect your insulin
needs. Other medicines, including prescription and non-prescription medicines,
vitamins, and herbal supplements, can change the way insulin works. You may
need a different dose of insulin when you are taking certain other medicines.
Know all the medicines you take, including prescription and non-prescription
medicines, vitamins, and herbal supplements. You may want to keep a list of the
medicines you take. You can show this list to your healthcare provider anytime
you get a new medicine or refill. Your healthcare provider will tell you if
your insulin dose needs to be changed.

Meals. The amount of food you eat can affect your
insulin needs. If you eat less food, skip meals, or eat more food than usual,
you may need a different dose of insulin. Talk to your healthcare provider if
you change your diet so that you know how to adjust your LANTUS and other
insulin doses.

Alcohol. Alcohol, including beer and wine, may
affect the way LANTUS works and affect your blood sugar levels. Talk to your
healthcare provider about drinking alcohol.

Exercise or Activity level. Exercise or activity
level may change the way your body uses insulin. Check with your healthcare
provider before you start an exercise program because your dose may need to be
changed.

Travel. If you travel across time zones, talk with
your healthcare provider about how to time your injections. When you travel,
wear your medical alert identification. Take extra insulin and supplies with
you.

Pregnancy or nursing. The effects of LANTUS on an
unborn child or on a nursing baby are unknown. Therefore, tell your healthcare
provider if you planning to have a baby, are pregnant, or nursing a baby. Good
control of diabetes is especially important during pregnancy and nursing.

Hypoglycemia is often called an “insulin
reaction” or “low blood sugar”. It may happen when you do not
have enough sugar in your blood. Common causes of hypoglycemia are illness,
emotional or physical stress, too much insulin, too little food or missed
meals, and too much exercise or activity. Early warning signs of hypoglycemia may
be different, less noticeable or not noticeable at all in some people. That is
why it is important to check your blood sugar as you have been advised by your
healthcare provider.

Hypoglycemia can happen with:

Taking too much insulin. This can happen when too
much insulin is injected.

Not enough carbohydrate (sugar or starch) intake. This can happen if a meal or snack is missed or delayed.

Vomiting or diarrhea that decreases the amount of
sugar absorbed by your body.

Intake of alcohol.

Medicines that affect insulin. Be sure to discuss
all your medicines with your healthcare provider. Do not start any new
medicines until you know how they may affect your insulin dose.

Medical conditions that can affect your blood sugar
levels or insulin. These conditions include diseases of the adrenal glands,
the pituitary, the thyroid gland, the liver, and the kidney.

Too much glucose use by the body. This can happen
if you exercise too much or have a fever.

Injecting insulin the wrong way or in the wrong
injection area.

Hypoglycemia can be mild to severe. Its onset may be
rapid. Some patients have few or no warning symptoms, including:

If you have hypoglycemia often or it is hard for you to
know if you have the symptoms of hypoglycemia, talk to your healthcare provider.

Mild to moderate hypoglycemia is treated by eating or
drinking carbohydrates, such as fruit juice, raisins, sugar candies, milk or
glucose tablets. Talk to your healthcare provider about the amount of
carbohydrates you should eat to treat mild to moderate hypoglycemia.

Severe hypoglycemia may require the help of another
person or emergency medical people. A person with hypoglycemia who is unable to
take foods or liquids with sugar by mouth, or is unconscious needs medical help
fast and will need treatment with a glucagon injection or glucose given
intravenously (IV). Without medical help right away, serious reactions or even
death could happen.

Hyperglycemia (high blood sugar):

Hyperglycemia happens when you have too much sugar in
your blood. Usually, it means there is not enough insulin to break down the
food you eat into energy your body can use. Hyperglycemia can be caused by a
fever, an infection, stress, eating more than you should, taking less insulin
than prescribed, or it can mean your diabetes is getting worse.

Hyperglycemia can happen with:

Insufficient (too little) insulin. This can happen
from:

injecting too little or no insulin

incorrect storage (freezing, excessive heat)

use after the expiration date.

Too much carbohydrate intake. This can happen if
you eat larger meals, eat more often, or increase the amount of carbohydrate in
your meals.

Medicines that affect insulin. Be sure to discuss
all your medicines with your healthcare provider. Do not start any new
medicines until you know how they may affect your insulin dose.

Testing your blood or urine often will let you know if
you have hyperglycemia. If your tests are often high, tell your healthcare
provider so your dose of insulin can be changed.

Hyperglycemia can be mild or severe. Hyperglycemia can progress
to diabetic ketoacidosis (DKA) or very high glucose levels (hyperosmolar coma)
and result in unconsciousness and death.

Although diabetic ketoacidosis occurs most often in
patients with type 1 diabetes, it can also happen in patients with type 2
diabetes who become very sick. Because some patients get few symptoms of
hyperglycemia, it is important to check your blood sugar/urine sugar and
ketones regularly.

Symptoms of hyperglycemia include:

confusion or drowsiness

increased thirst

decreased appetite, nausea, or vomiting

rapid heart rate

increased urination and dehydration (too little fluid in
your body).

Symptoms of DKA also include:

fruity smelling breath

fast, deep breathing

stomach area (abdominal) pain.

Severe or continuing hyperglycemia or DKA needs
evaluation and treatment right away by your healthcare provider.

Do not use LANTUS to treat diabetic ketoacidosis.

Other possible side effects of LANTUS include:

Serious allergic reactions:

Some times severe, life-threatening allergic reactions
can happen with insulin. If you think you are having a severe allergic
reaction, get medical help right away. Signs of insulin allergy include:

rash all over your body

shortness of breath

wheezing (trouble breathing)

fast pulse

sweating

low blood pressure.

Reactions at the injection site:

Injecting insulin can cause the following reactions on
the skin at the injection site:

little depression in the skin (lipoatrophy)

skin thickening (lipohypertrophy)

red, swelling, itchy skin (injection site reaction).

You can reduce the chance of getting an injection site
reaction if you change (rotate) the injection site each time. An injection site
reaction should clear up in a few days or a few weeks. If injection site
reactions do not go away or keep happening, call your healthcare provider.

Tell your healthcare provider if you have any side
effects that bother you.

These are not all the side effects of LANTUS. Ask your
healthcare provider or pharmacist for more information.

How should I store LANTUS?

Unopened vial:
Store new (unopened) LANTUS vials in a refrigerator (not the freezer)
between 36°F to 46°F (2°C to 8°C). Do not freeze LANTUS. Keep LANTUS out of
direct heat and light. If a vial has been frozen or overheated, throw it away.

Open (In-Use) vial:
Once a vial is opened, you can keep it in a refrigerator or at room temperature
(below 86°F [30°C]) but away from direct heat and light. Opened vial, either
kept in a refrigerator or at room temperature, should be discarded 28 days
after the first use even if it still contains LANTUS. Do not leave your insulin
in a car on a summer day.

These storage conditions are summarized in the following
table:

Not in-use (unopened) Refrigerated

Not in-use (unopened) Room Temperature

In-use (opened) (See Temperature Below)

10 mL Vial

Until expiration date

28 days

28 days Refrigerated or roomtemperature

Do not use a vial of LANTUS
after the expiration date stamped on the label.

Do not use LANTUS if it is
cloudy, colored, or if you see particles.

General Information about
LANTUS

Use LANTUS only to treat your
diabetes. Do not give or share LANTUS with another person, even if they
have diabetes also. It may harm them.

This leaflet summarizes the
most important information about LANTUS. If you would like more information,
talk with your healthcare provider. You can ask your doctor or pharmacist for
information about LANTUS that is written for healthcare professionals. For more
information about LANTUS call 1-800-633-1610 or go to website www.lantus.com.

ADDITIONAL INFORMATION

DIABETES FORECAST is a national magazine designed
especially for patients with diabetes and their families and is available by
subscription from the American Diabetes Association (ADA), P.O.Box 363, Mt.
Morris, IL 61054-0363, 1-800-DIABETES (1-800-342-2383). You may also visit the
ADA website at www.diabetes.org. Another publication, COUNTDOWN, is available
from the Juvenile Diabetes Research Foundation International (JDRF), 120 Wall
Street, 19th Floor, New York, New York 10005, 1800-JDF-CURE (1-800-533-2873).
You may also visit the JDRF website at www.jdf.org.

To get more information about diabetes, check with your
healthcare professional or diabetes educator or visit www.DiabetesWatch.com.

Additional information about LANTUS can be obtained by
calling 1-800-633-1610 or by visiting www.lantus.com.

LANTUS® SOLOSTAR®
(insulin glargine [rDNA origin] injection)

Instruction Leaflet

Your healthcare professional has decided that SoloStar® is right for you. Talk with your healthcare professional about proper
injection technique before using SoloStar® .

Read these instructions carefully before using your
SoloStar®. If you are not able to follow all the instructions
completely on your own, use SoloStar® only if you have help from a
person who is able to follow the instructions.

Follow these instructions completely each time you use
SoloStar® to ensure that you get an accurate dose. If you do not
follow these instructions you may get too much or too little insulin, which may
affect your blood glucose.

SoloStar® is a disposable pen for the
injection of insulin. Each SoloStar® contains in total 300 units of
insulin. You can set doses from 1 to 80 units in steps of 1 unit. The pen plunger
moves with each dose. The plunger will only move to the end of the cartridge
when 300 units of insulin have been given.

Keep this leaflet for future reference.

If you have any questions about SoloStar® or
about diabetes, ask your healthcare professional, go to www.lantus.com or call
sanofi-aventis at 1-800-633-1610.

Important information for
use of SoloStar®:

Always attach a new needle
before each use. BD Ultra-Fine needles are compatible with SoloStar®.
These are sold separately and are manufactured by BD. Contact your healthcare
professional for further information.

Always perform the safety test
before each injection.

Do not select a dose or press
the injection button without a needle attached.

This pen is only for your use.
Do not share it with anyone else.

If your injection is given by
another person, special caution must be taken by this person to avoid accidental
needle injury and transmission of infection.

Never use SoloStar® if
it is damaged or if you are not sure that it is working properly.

Always have a spare SoloStar® in case your SoloStar® is lost or damaged.

Storage Instructions

Please check the leaflet for
the insulin for complete instructions on how to store SoloStar® .

If your SoloStar® is in cool storage, take it
out 1 to 2 hours before you inject to allow it to warm up. Cold insulin is more
painful to inject.

Keep SoloStar® out of the reach and sight of
children.

Keep your SoloStar® in cool storage (36°F -
46°F [2°C – 8°C]) until first use. Do not allow it to freeze. Do not put it
next to the freezer compartment of your refrigerator, or next to a freezer
pack.

Once you take your SoloStar® out of cool
storage, for use or as a spare, you can use it for up to 28 days. During this
time it can be safely kept at room temperature up to 86°F (30°C). Do not use it
after this time. SoloStar® in use must not be stored in a
refrigerator.

Do not use SoloStar® after the expiration date
printed on the label of the pen or on the carton.

Protect SoloStar® from light.

Discard your used SoloStar® as required by
your local authorities.

Maintenance

Protect your SoloStar® from
dust and dirt.

You can clean the outside of
your SoloStar® by wiping it with a damp cloth.

Do not soak, wash or lubricate
the pen as this may damage it.

Your SoloStar® is
designed to work accurately and safely. It should be handled with care. Avoid

situations where SoloStar® might be damaged. If you are concerned that your SoloStar® may
be damaged, use a new one.

Step 1. Check the insulin

A. Check the label on your SoloStar® to make
sure you have the correct insulin. The Lantus® SoloStar® is
grey with a purple injection button.

B. Take off the pen cap.

C. Check the appearance of your insulin. Lantus® is
a clear insulin. Do not use this SoloStar® if the insulin is cloudy,
colored or has particles.

Step 2. Attach the needle

Always use a new sterile needle for each injection. This
helps prevent contamination, and potential needle blocks.

A. Wipe the Rubber Seal with alcohol.

B. Remove the protective seal from a new needle.

C. Line up the needle with the pen, and keep it straight
as you attach it (screw or push on, depending on the needle type)

If the needle is not kept
straight while you attach it, it can damage the rubber seal and cause leakage,
or break the needle.

Step 3. Perform a Safety test

Always perform the safety test before each injection.

Performing the safety test
ensures that you get an accurate dose by:

ensuring that pen and needle
work properly

removing air bubbles

A. Select a dose of 2 units by turning the dosage
selector.

B. Take off the outer needle
cap and keep it to remove the used needle after injection. Take off the
inner needle cap and discard it

C. Hold the pen with the needle
pointing upwards.

D. Tap the insulin reservoir so
that any air bubbles rise up towards the needle.

E. Press the injection button
all the way in. Check if insulin comes out of the needle tip.

You may have to perform the
safety test several times before insulin is seen.

If no insulin comes out, check
for air bubbles and repeat the safety test two more times to remove them.

If still no insulin comes out,
the needle may be blocked. Change the needle and try again.

If no insulin comes out after changing the needle, your
SoloStar® may be damaged. Do not use this SoloStar® .

Step 4. Select the dose

You can set the dose in steps
of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If you need a
dose greater than 80 units, you should give it as two or more injections.

A. Check that the dose window
shows “0” following the safety test.

B. Select your required dose (in the example below, the
selected dose is 30 units). If you turn past your dose, you can turn back down.

Do not push the injection
button while turning, as insulin will come out.

You cannot turn the dosage
selector past the number of units left in the pen. Do not force the dosage
selector to turn. In this case, either you can inject what is remaining in the
pen and complete your dose with a new SoloStar® or use a new
SoloStar® for your full dose.

Step 5. Inject the dose

A. Use the injection method as
instructed by your healthcare professional.

B. Insert the needle into the skin.

C. Deliver the dose by pressing
the injection button in all the way. The number in the dose window will return
to “0” as you inject.

D. Keep the injection button
pressed all the way in.

Slowly count to 10 before
you withdraw the needle from the skin.
This ensures that the full dose will be delivered.

Step 6. Remove and discard
the needle

Always remove the needle after each
injection and store SoloStar® without a needle attached. This helps prevent:

Contamination and/or infection

Entry of air into the insulin
reservoir and leakage of insulin, which can cause inaccurate dosing.

A. Put the outer needle cap back on the needle, and use
it to unscrew the needle from the pen. To reduce the risk of accidental needle
injury, never replace the inner needle cap.

If your injection is given by another person, special
caution must be taken by this person when removing and disposing the needle.
Follow recommended safety measures for removal and disposal of needles (e.g. a
one handed capping technique) in order to reduce the risk of accidental needle
injury and transmission of infectious diseases.

B. Dispose of the needle safely. Used needles should be
placed in sharps containers (such as red biohazard containers), hard plastic
containers (such as detergent bottles), or metal containers (such as an empty
coffee can). Such containers should be sealed and disposed of properly. If you
are giving an injection to a third person, you should remove the needle in an
approved manner to avoid needle-stick injuries.

C. Always put the pen cap back on the pen, then store the
pen until your next injection.

Last reviewed on RxList: 6/17/2013
This monograph has been modified to include the generic and brand name in many instances.